User Manual: Vacuklav 24 B+ Vacuklav 30 B+

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User Manual

Vacuklav® 24 B+
Vacuklav® 30 B+
Steam sterilizer
from software version 5.17

EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world’s leading manufacturer in the instrument treatment and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing “competence in
hygiene” and “Quality – made in Germany”, we guarantee that these demands will be met. Our certified quality man-
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.
The MELAG management and team.
Contents

Contents
1 General guidelines ............................................................................................................................................................... 5
Symbols used....................................................................................................................................................................... 5
Formatting rules ................................................................................................................................................................... 5

2 Safety..................................................................................................................................................................................... 6

3 Performance specifications ................................................................................................................................................ 8


Intended use ........................................................................................................................................................................ 8
Sterilization procedure ......................................................................................................................................................... 8
Type of the feed water supply .............................................................................................................................................. 8
Safety equipment ................................................................................................................................................................. 9
Overview of sterilization programs ....................................................................................................................................... 9
Program sequences ........................................................................................................................................................... 10
Overview of programs ........................................................................................................................................................ 11

4 Description of the device................................................................................................................................................... 13


Scope of delivery................................................................................................................................................................ 13
Views of the device ............................................................................................................................................................ 14
Symbols on the device ....................................................................................................................................................... 15
Operating panel.................................................................................................................................................................. 16
Load mounts ...................................................................................................................................................................... 17

5 First steps ........................................................................................................................................................................... 18


Setup and installation......................................................................................................................................................... 18
Feed water supply.............................................................................................................................................................. 18
Supply with cooling water................................................................................................................................................... 18
Switching on the steam sterilizer........................................................................................................................................ 19
Opening and closing the door ............................................................................................................................................ 19
Setting the date and time ................................................................................................................................................... 19

6 Loading the steam sterilizer .............................................................................................................................................. 21


Preparing the sterilization material..................................................................................................................................... 21
Loading the steam sterilizer ............................................................................................................................................... 22

7 Sterilization ......................................................................................................................................................................... 24
Important information regarding routine operation ............................................................................................................. 24
Selecting the program ........................................................................................................................................................ 25
Additional program options ................................................................................................................................................ 26
Starting the program .......................................................................................................................................................... 27
Program run ....................................................................................................................................................................... 27
Program end ...................................................................................................................................................................... 28
Manual program abort........................................................................................................................................................ 28
Removing the sterilized equipment .................................................................................................................................... 30
Storing sterile instruments.................................................................................................................................................. 30

8 Logging ............................................................................................................................................................................... 31
Batch documentation ......................................................................................................................................................... 31
Output media...................................................................................................................................................................... 32
Outputting logs immediately and automatically.................................................................................................................. 34
Subsequent log output ....................................................................................................................................................... 35
Contents

Displaying the log memory................................................................................................................................................. 36


Deleting logs in the internal log memory ............................................................................................................................ 36
Reading logs correctly........................................................................................................................................................ 37

9 Function tests ..................................................................................................................................................................... 39


Automatic functional checks............................................................................................................................................... 39
Manual functional checks................................................................................................................................................... 39
Batch-related tests ............................................................................................................................................................. 39
Vacuum test ....................................................................................................................................................................... 39
Bowie & Dick test ............................................................................................................................................................... 40
Checking the quality of the feed water ............................................................................................................................... 40
Checking the preheating temperature of the chamber....................................................................................................... 41

10 Maintenance...................................................................................................................................................................... 42
Servicing intervals .............................................................................................................................................................. 42
Cleaning ............................................................................................................................................................................. 42
Avoiding staining ................................................................................................................................................................ 43
Replacing the door seal ..................................................................................................................................................... 43
Replacing or sterilizing the sterile filter............................................................................................................................... 44
Cleaning the filter in the chamber ...................................................................................................................................... 46
Maintenance....................................................................................................................................................................... 46

11 Pause times ...................................................................................................................................................................... 47


Frequency of sterilization ................................................................................................................................................... 47
Operating pauses............................................................................................................................................................... 47
Decommissioning............................................................................................................................................................... 47
Recommissioning after relocation ...................................................................................................................................... 47

12 Malfunctions ..................................................................................................................................................................... 48
General events................................................................................................................................................................... 48
Warnings ............................................................................................................................................................................ 49
Malfunction messages ....................................................................................................................................................... 52
Opening the door in an emergency following a power outage ........................................................................................... 57
Replacing the device fuses ................................................................................................................................................ 58

13 Technical data .................................................................................................................................................................. 59

14 Accessories and spare parts .......................................................................................................................................... 60

Glossary ................................................................................................................................................................................. 61
1 General guidelines

1 General guidelines

Read this user manual carefully before commissioning the device. The user manual includes important
safety information. The functionality and value-retention of this device depends on the care accorded to it.
Store this user manual carefully and in close proximity to your device. It represents a component of the
product.
Should the user manual no longer be legible, damaged or lost, obtain a new copy from MELAG. State the
device type and your address in an e-mail.
The device type is specified on the type plate on the rear of the device.

Symbols used
Symbol Explanation
Indicates a dangerous situation, which if not avoided, could entail slight to life-
threatening injuries.
Draws your attention to a situation, which if not avoided, could result in damage to the
instruments, the practice fittings or the device.
Draws your attention to important information.

Formatting rules
Example Explanation
see Chapter 2 Reference to another text section within this document.
Universal- Words or phrases appearing on the display of the device are marked as display text.
Program

5
2 Safety

2 Safety

When operating the device, comply with the following safety instructions as well as those
contained in subsequent chapters. Use the device only for the purpose specified in these
instructions. Failure to comply with the safety instructions can result in injury and/or damage to
the device.
Qualified personnel
n As with the preceding instrument decontamination, the sterilization of instruments and textiles using
this steam sterilizer may only be carried out by competent personnel.
Carrying the steam sterilizer
n The device should always be carried by two people.
n Use the correct carrying straps to carry the device.
Set-up, installation and commissioning
n Check the device for any damage suffered during transport after unpacking.
n The device should only be set-up, installed and commissioned by MELAG authorized technicians.
n The connections for electrical provision and water supply and discharge must be set-up by trained
personnel.
n Using the optional electronic leak detector (water stop) minimizes the risk of water damage.
n The device is not suitable for operation in explosive atmospheres.
n Install and operate the device in a frost-free environment.
n The device is conceived for use outside the patient area. The device should be located a minimum of
1.5 m radius away from the treatment area.
n The documentation media (computer, CF card reader etc.) must be placed in such a way that they
cannot come into contact with liquids.
n Observe all the information contained in the technical manual during commissioning.
Power cable and power plug
n Comply with all legal requirements and locally-specified connection conditions.
n Never operate the device if the plug or power cable are damaged.
n The power cable or plug should only be replaced by authorized technicians.
n Never damage or alter the power plug or cable.
n Never unplug by pulling on the power cable. Always take a grip on the plug.
n Ensure that the power cable does not become jammed in.
n Never lead the cable along a source of heat.
n Never fix the power cable with sharp objects.
Spring loaded safety valve
n The free movement of the valve rod must be guaranteed. For example, the spring safety valve must
not be taped or blocked. Install the device in such a way that the proper functioning of the spring
loaded safety valve is guaranteed.
Decontamination and sterilization
n Follow the manufacturer’s instructions of your textile articles and instruments regarding their decon-
tamination and sterilization.
n Comply with the relevant standards and directives applicable to the decontamination and sterilization
of textiles and instruments in Germany e.g. from the RKI and DGSV.
n Only ever use packaging material and systems which have been cleared by their manufacturer for
steam sterilization.

6
2 Safety

Program abort
n Please observe that depending on the time of the program abort, opening the door following a pro-
gram abort can lead to hot steam leaving the chamber.
n Depending on the time of the program abort, it is possible that the load is unsterile. Observe the clear
instructions shown on the display of the steam sterilizer. If necessary, sterilize the affected objects
after rewrapping.
Removing the sterilized equipment
n Never use force to open the door.
n Use a tray jack to remove the tray. Never touch the sterilized items, the chamber or the door with
unprotected hands. The components are hot.
n Check the packaging on the sterilized equipment for damage when removing it from the steam
sterilizer. Should the packaging be damaged, re-pack the sterilization material and re-sterilize it.
Transport and storage
n Store and transport the device in a frost-free environment.
n The device should always be carried by two people.
n Use suitable carrying straps to carry the device.
Maintenance
n Maintenance should only be performed by authorized technicians.
n Maintain the specified servicing intervals.
n Only original MELAG spare parts may be used.
Malfunctions
n Should the device issue the same malfunction message repeatedly, turn off the device and if
necessary, inform your stockist.
n The device may only be serviced by authorized technicians.
Notification requirement in the event of serious accidents in the European Economic Area
n Please note that all serious accidents which occur in connection with the medical product (e.g. death
or serious deterioration in the state of health of a patient) which were presumably caused by the
product, must be reported to the manufacturer (MELAG) and the relevant authority of the member
state, in which the user and/or patient resides.

7
3 Performance specifications

3 Performance specifications

Intended use
This steam sterilizer is designed for application in a medical context, e.g. general practitioners and dental
practices. According to DIN EN 13060, this steam sterilizer is considered as a steam sterilizer with type B
cycles. As an universal steam sterilizer, it is suited to highly-demanding sterilization tasks. It can be used
for a range of tasks such as the sterilization of large quantities of instruments with narrow lumen and trans-
mission instruments - both wrapped or unwrapped - and of textiles.

WARNING
Any attempt to sterilize liquids can result in a delay in boiling. This can result in burns
and damage to the device.
n Never use this device to sterilize fluids. It is not licensed for the sterilization of fluids.

Sterilization procedure
The steam sterilizer sterilizes on the basis of the fractionated vacuum procedure. This guarantees the
complete and effective wetting/penetration of the sterilization material with saturated steam.
The steam sterilizer uses a separate steam generator to generate sterilizing steam. Steam is generated
upon program start and led into the sterilization chamber. This establishes a pre-defined pressure and
temperature. The sterilization chamber is protected against overheating. You can sterilize large quantities
of instruments or textiles directly one after each other, thereby achieving excellent drying results.

Automatic preheating
If preheating is activated, the cold chamber is heated up to the preheating temperature of the particular
program before program start, or this temperature is held between two program runs. This reduces pro-
gram times and reduces the accretion of condensation, thus improving drying results.

Type of the feed water supply


The steam sterilizer works with a one-way feed water system. This means that it uses fresh feed water
(demineralized or distilled water) for every sterilization procedure. The quality of the feed water is subject
to permanent monitoring via integrated conductivity measurement. If combined with instrument decontami-
nation of the instruments, this serves largely to prevent stain accretion on the instruments and soiling of
the steam sterilizer.

Automatic feed water supply


The supply with feed water for the steam generation is performed automatically via an external water
storage container (art. no. 00244) or a water treatment unit (e.g. MELAdem 40, MELAdem 47).
The technical manual provides detailed information regarding connection to a water treatment unit.

8
3 Performance specifications

Safety equipment
Internal process monitoring
A process evaluation system is integrated in the electronics of the steam sterilizer. It compares the process
parameters (such as temperature, time and pressure) during a program run. It monitors the parameters in
terms of their threshold values during control and regulation and guarantees safe and successful
sterilization. A monitoring system checks the device components of the steam sterilizer for their
functionality and their plausible interaction. If one or more parameters exceeds pre-determined threshold
values, the steam sterilizer issues warnings or malfunction messages and if necessary, aborts the pro-
gram. In the case of a program abort, follow the instructions on the display.
The steam sterilizer uses an electronic parameter control. This enables the steam sterilizer to optimize the
total operating time of a program in dependence on the load.

Door mechanism
The steam sterilizer constantly checks pressure and temperature in the sterilization chamber and prevents
the door from being opened when over-pressure has built up in the chamber.

Quantity and quality of the feed water


The quantity and quality of the feed water is automatically checked before every program start.

Overview of sterilization programs


The results in this table show which inspections were performed on the steam sterilizer. The marked field
shows compliance with all the applicable sections of the standard DIN EN 13060.

Type tests Universal- Quick- Quick- Gentle- Prion-


Program Program B Program S Program Program
Program type in Type B Type B Type S Type B Type B
accordance with
DIN EN 13060
Dynamic pressure test of X X -- X X
the sterilization chamber
Air leakage X X X X X
Empty chamber test X X X X X
Solid load X X X X X
Porous partial load X -- -- X X
Porous full load X -- -- X X
Simple hollow body -- -- X -- --
(Hollow body B)
Product with narrow X X -- X X
lumen (Hollow body A)
Single wrapping X X -- X X
Multiple wrapping X -- -- X X
Drying solid load X X X X X
Drying porous load X -- -- X X
Sterilization temperature 134 °C 134 °C 134 °C 121 °C 134 °C
Sterilization pressure 2.1 bar 2.1 bar 2.1 bar 1.1 bar 2.1 bar
Sterilization time 5:30 min 5:30 min 3:30 min 20:30 min 20:30 min
X = Complies with all applicable sections of the standard DIN EN 13060

9
3 Performance specifications

Program sequences
Regular sterilization program
A program runs in three phases: air removal, sterilization and drying phase. After program start, you can
follow the program run on the display. It shows the chamber temperature and pressure as well as the time
until the end of sterilization / drying.

Program phase Description


1. Air removal phase The air removal phase comprises the conditioning and the evacuation phase.
(fractionation) During conditioning, steam is repeatedly injected into the sterilization chamber to
generate over-pressure. The mixture of air and steam is then removed
repeatedly (evacuation). This procedure is also called the fractionated vacuum
procedure.
2. Heating phase The heating phase follows the air removal phase. The continued steam intake
into the chamber leads to an increase in pressure and temperature which
continues until the program-specific sterilization parameters have been reached.
3. Sterilization phase Once the pressure and temperature correspond to the program-dependent
nominal values, the actual sterilization phase begins. The sterilization time is
indicated on the display.
4. Pressure release The end of the sterilization phase is followed by pressure release with
simultaneous emptying of the steam generator.
5. Drying phase The sterilization material is dried using a vacuum (vacuum drying). The drying
phase begins after the pressure release. Upon program end, the chamber is
filled with sterile air via the air filter and adjusted to the ambient pressure.
6. Ventilation Once the program has come to an end, the chamber pressure is adapted to the
ambient pressure. The corresponding display notification "ventilation" is
displayed.

Vacuum test
The vacuum test measures the leakage rate. No real sterilization is performed. The test is performed with
a cold, dry and unloaded device.

Program phase Description


1. Air removal phase The chamber is evacuated until the pressure for the vacuum test has been
(evacuation) reached.
2. Equilibration time An equilibration time of five minutes will follow.
3. Measurement time The measurement time amounts to ten minutes. The pressure increase within
the chamber is measured during the measurement time. The evacuation
pressure and the equilibration time or measurement time are shown on the
display.
4. Test end The display shows the test result, the batch number, the total number of batches
and the leakage rate.

10
3 Performance specifications

Overview of programs
MAIN menu

Initial state - Function


+ (see next page)
Press 1x
hh:mm:ss AIN6: Conductivity Press simultaneously to navigate
0.00 bar 89°C h - - +
10 µS/cm to the SETUP menu Function
Release
P h - Select by holding the '-’ key
depressed
Press 2x
+ Unlock the door with the '+’ key
Universal-Program AIN4: Temp_pre-heat.
134°C wrapped
h -
120°C
Release
P S+
Additional drying selected
Quick-Program S
134°C

Program run
P
Abort before
Quick-Program B S drying
134°C START
-------- Program running --------

S Cancel program?
P 'Stop’ key

Gentle-Program S
121°C
Program
P aborted
Abort during
Pressure release
Prion-Program drying 1.52 bar 112°C
134°C wrapped 20'
Stop / End
P Immediate removal Cancel programm 0.02 bar 88°C
press 'Stop' 'Stop’ key
Acknowledge
Bowie & Dick-Test S with '-’ key
134°C 2.2 bar 3.5'
Quick-Program B Drying
run successfully aborted
-
P

Last batch number x Unlock door


Vacuum test Acknowledge with '+' with '+’ key

S+ Press the 'S' and '+’ keys simultaneously

S 'Start-Stop’ key and program abort

P 'Program' key: Enter, confirm, entry

11
3 Performance specifications
Functions of the SETUP menu
12

hh:mm:ss
0.00 bar 89°C Initial state

S - + Press both keys simultaneously


1 No output medium
MELAprint
SETUP menu
MELAflash
Function: 2
MELAnet graphic data (MELAnet Box) Applies only to Vacuklav 23 B+/ 31 B+, Euroklav S+/ VS+, Vacuvet 23 B+
Computer 3
Modem Applies only to Euroklav S+/ VS+

Last Log Autom. Feed water


batch number: Total batches Date / time output preheating inflow 2 Water system3

S P S P S P S P S P S P S P

Last batch number Total batches Date / time P 1 P No Internal One-way


Hour: xx Output medium:
xx xx + +
S S
- -
P P Yes External Circulation
Date / time Immediate output
Minute: xx = see above Yes/No S
P P P
P
Date / time
Second: xx
= see above Output P
last cycle: No. xx
+ S + -
- Date / time - +
= see above
Day: xx P
Output
stored cycles S
Date / time
Month: xx
= see above P + - Selector keys: "Next" (forwards/back) in the menu loop
Occupied: xx P Program selection key: “Enter/Confirm/Entry”
Free: xx
Date / time
Year: xx
= see above S Start/Stop key: "Abort/Escape/Leave"

Delete S Start/Stop key: "Escape/Leave" without saving


all cycles S
+ -
P Page forwards through the main and submenu loop
with the '+' key and backwards with the '-' key. The 'S’
Test output key enables you to leave the menu at any time.
S
P
+ -
4 Description of the device

4 Description of the device

Scope of delivery
Please check the scope of delivery before setting up and connecting the device.

Standard scope of delivery


▪ Vacuklav 24 B+ or Vacuklav 30 B+
▪ User manual
▪ Usage instructions for mounts
▪ Technical manual
▪ Warranty certificate
▪ Manufacturer's inspection report and declaration of conformity
▪ Record of installation and setting up
▪ Wastewater hose, PVC fabric, 2 m
▪ Pressure hose water inflow, 2.5 m
▪ Tray lifter
▪ Key for the chamber filter
▪ Guide sleeve
▪ Feed water connection
▪ Double chamber siphon
▪ Lever for emergency release of the door
▪ 2x Replacement device fuse on the inside of the steam sterilizer door

13
4 Description of the device

Views of the device

3 1 Operating and display panel


2 Door, swings open to the left
3 Locking slider
4 Power switch
5 Front device foot (adjustable)

Fig. 1: View from front

6
7

6 Cooling water inflow (3/4” external


thread)
8
7 Safety combination in accordance
with EN 1717
9
8 Spring safety valve
9 Sterile filter
10 10 Cooling water outlet (3/4” external
thread)
11 Feed water inflow for external
water storage container or
MELAdem, swivel screw
connection for hose Ø 6x1
12 Mains connection

12 11

Fig. 2: View from rear

14
4 Description of the device

13 Chamber
13 14 Door locking pin
15 Chamber sealing face
14
16 Cap for emergency activation of
the vacuum pump
15
17 2x Device fuse
18 Motor protection switch reset
16 button
19 Serial data and printer connection
(RS232)1)
20 Door seal
21 20 19 18 17 21 Round blank
Fig. 3: View of the interior

Symbols on the device

Manufacturer of the medical device

Date of manufacture of the medical device

Medical device serial number from the manufacturer

Article number of the medical device

Information about the chamber volume

Operating temperature of the device

Operating pressure of the device

The user manual includes important safety information. Failure to comply with these
instructions can result in injury and material damage.

Please read this user manual carefully before commissioning the device.

In affixing this CE mark, the manufacturer declares that this medical product fulfils the
basic requirements of the Medical device directive. The four-digit number confirms that
this is monitored by an approved certification agency.

1)
hidden behind white cover

15
4 Description of the device

In affixing this CE mark, the manufacturer declares that this product fulfils the basic
requirements of the Pressure equipment directive. The four-digit number confirms that
this is monitored by an approved certification agency.
With the adjacent label, the device manufacturer declares that the medical product
corresponds to the basic requirements of the European standard EN 1717 - Protecting
Drinking Water from Contamination.

The device may not be disposed as domestic waste. The vendor is responsible for
appropriate disposal of the device - it must be delivered to the vendor to be disposed of.
MELAG devices are synonymous for long-term quality. When you eventually need to
decommission your MELAG device, we offer a special disposal service. Simply contact
your stockist.

Operating panel
The operating panel consists of a two-row alphanumerical LC display and four membrane keys.

1 2 3

14:27:12
0,02bar 25 °C

4 5 6

1 2-row LC display
for display of the program status and parameters
2 Time (h:min:s)
3 Chamber pressure (bar) and (steam) temperature (°C)
4 Function keys '-' and '+'
for the selection, setting and display of special functions: printing, date / time, preheating, total
batches, conductivity, acknowledge malfunction, '+' key for unlocking the door
5 Program selection key 'P'
for selecting the sterilization program / test program and selection / setting of the options
(submenus) of the special functions
6 Start – Stop key 'S'
for starting programs, aborting programs / drying and controlling the special functions

Initial state
The display switches to the initial state after every activation of the device. This displays the current time,
the chamber pressure in bar and the (steam) temperature in °C.

16
4 Description of the device

Load mounts
Detailed information regarding the various mounts, their combinability with various load holders and their
application can be found in the separate document “Usage instructions for mounts”.

Mount A Plus
The mount (A Plus) is standard and can
accommodate either five trays or three MELAstore
Boxes 100 when turned 90˚.

Mount D
The mount (D) can accommodate two tall
sterilization containers (e.g. MELAstore Box 200) or
four trays (when turned 90°).

17
5 First steps

5 First steps

Setup and installation

PLEASE NOTE
Comply with the specifications of the technical manual during set-up and installation.
This contains all building-side requirements.

Record of installation and setting up


The record of installation and setting up is to be completed by the responsible stockist and a copy sent to
MELAG as proof of the correct set-up, installation and initial commissioning. This is a constituent part of
any guarantee claim.

Feed water supply


Steam sterilization requires the use of distilled or demineralized water, known as feed water.
DIN EN 13060 requires that feed water is to be used in accordance with the guideline values in
appendix C.
The supply with feed water is effected via an external water storage container, which must be filled
periodically with water of the corresponding quality, either manually or automatically via a water treatment
unit (e.g. MELAdem 40 / MELAdem 47).

Using the external water storage container


The storage container has a capacity of 11.5 l. This volume of feed water is sufficient for up to approx. 25
sterilization runs. Fill the storage container with feed water. The water level of the storage container may
not fall below the MIN mark during operation. Check the water level in the storage container before every
program start.

NOTICE
Danger of algae development
n To prevent the development of algae, never expose the storage container to sunlight.

Use of a water treatment unit


A water treatment unit is connected to the drinking water supply. This obviates the need to fill the storage
container. The respective system is selected in accordance with the number of sterilization runs per day
and the type of the load. Every MELAG steam sterilizer can be fitted with a water treatment unit.

PLEASE NOTE
Should you wish to use a water treatment unit from another manufacturer, please consult
MELAG.

Supply with cooling water


The vacuum pump of the steam sterilizer and the water treatment unit require tap water for operation.
The connection of the steam sterilizer to the water supply is comparable with the connection of a washing
machine in a domestic context. Detailed information regarding the connection to the water line is provided
in the technical manual.
The used water is disposed via the on-site effluent system.

18
5 First steps

Switching on the steam sterilizer


ü The steam sterilizer is connected to the electricity supply.

} The steam sterilizer is switched on at the power switch.


The display switches between the initial state and the notification Unlock door with '+' key, if the
door is closed.

PLEASE NOTE
All accessories must be removed from the chamber directly after the steam sterilizer has
been switched on for the first time and before initial commissioning.

After device activation, a heating up time of approx. 5 min (Vacuklav 24 B+) or approx. 3 min
(Vacuklav 30 B+) is required depending on the device type. A program will be started only after the target
temperature has been reached.

PLEASE NOTE
When switching off the device via the power switch, wait three seconds before switching
it back on.

Opening and closing the door


The door can only be opened when the display shows: Acknow. with '+' key / Unlock door
with '+' key.
1. Press the '+' key. You can open the door after hearing an audible click.
2. To shut the door, press it against the chamber flange and slide the locking slider downwards to its at
the same time.

Setting the date and time


Correct batch documentation requires the correct date and time setting on the steam sterilizer. Ensure that
you take into account the clock change in autumn and summer, as this is not adjusted automatically. Set
the date and time as follows:
1. Select menu Function by pressing the '+' and '-' keys simultaneously.
Ê The display will show the message Function: Last batch number.
2. Navigate in the Function menu using the '+' or '-' keys until the display shows:

Function
Date / time

3. Press the 'P' key to confirm.


Ê The current hour is displayed.
4. Choose one of the following setting possibilities using the '+' or '-' keys: hour, minute, second, day,
month, year.
5. For example, to adjust the hour parameter, press the 'P' key to confirm.
Ê The current value flashes on the display.
6. You can increase or reduce the value using the '+' and '-' keys.
7. Press the 'P' key to confirm.
Ê The current value set no longer flashes on the display.
8. Proceed in a similar fashion to alter the other parameters.

19
5 First steps

9. After ending the settings, press the 'S' key to leave the menu.
Ê The display will show the message Function: Date / Time.
10. Repeated pressing of the 'S' key enables you to leave the menu and the display returns to its initial
state.

20
6 Loading the steam sterilizer

6 Loading the steam sterilizer

Preparing the sterilization material


Cleaning and disinfection must always have been performed correctly and appropriately before steriliza-
tion. Only in this way is it possible to guarantee the subsequent sterilization of the sterilization material.
The materials used, cleaning agents and decontamination procedure are of decisive significance.

NOTICE
Only ever operate the steam sterilizer with a sterile filter inserted.

Decontaminating textiles

WARNING
The incorrect decontamination of textiles, e.g. a textile package can prevent steam
penetration and/or produce poor drying results. The textiles could not be sterilized.
This could endanger the health of patient and practice team.

Comply with the following when decontaminating textiles and putting the textiles in sterilization containers:
u Comply with both the manufacturer's instructions of the textiles regarding decontamination and
sterilization as well as the relevant standards and directives e.g. from the RKI and DGSV.
u Arrange the folds in the textiles parallel to each other.
u Stack textiles vertically wherever possible and not too closely together in the sterilization container.
This enables the development of flow channels.
u If textile packages do not remain together, wrap the textiles in sterilization paper.
u Only ever sterilize dry textiles.
u The textiles may not be permitted to come into direct contact with the sterilization chamber; otherwise
they will become saturated with condensate.

Decontaminating the instruments

WARNING
The incorrect decontamination of instruments could result in any dirt residue being
loosened by the steam pressure during sterilization.
The use of unsuitable care agents e.g. water repellent agents or oils impermeable to
steam could result in unsterile instruments. This represents a danger to the health of
both patients and yourself.

NOTICE
The presence of residual disinfection and cleaning fluids results in corrosion.
This could result in increased maintenance requirements and a restriction of the steam
sterilizer function.

Unwrapped sterile material loses its sterility on contact with ambient air. If you intend to store your instru-
ments sterilely, wrap them in suitable packaging before sterilization.

21
6 Loading the steam sterilizer

Ensure the following when decontaminating used and brand-new instruments:


u Follow both the instrument manufacturer’s instructions regarding decontamination and sterilization and
comply with the relevant standards and directives e.g. from the BGV A1, RKI and DGSV.
u Clean the instruments exceptionally thoroughly e.g. using an ultrasonic device or washer-disinfector.
u Rinse the instruments after washing and disinfecting, where possible with de-mineralized or distilled
water and then dry the instruments thoroughly with a clean, non-fuzzing cloth.
u Use only those care agents suitable for steam sterilization. Consult the manufacturer of the care
agents. Do not use any water repellent agents or oils impermeable to steam.
u When using ultrasound devices, care equipment for handpieces and washer-disinfectors, please
comply with the manufacturer’s decontamination instructions.

Loading the steam sterilizer


Effective sterilization and good drying is only possible if the steam sterilizer has been loaded correctly.
Ensure the following during loading:
u Insert trays or cassettes in the chamber only with their appropriate mount.
u Use perforated trays such as those from MELAG. Only in this way can condensate drain off. The use
of a non-perforated base or half-shell to accommodate the sterilization material can result in poor
drying results.
u The use of paper tray inserts can also result in poor drying results.
u Wherever possible, please ensure the separate sterilization of textiles and instruments in separate
sterilization containers or sterilization packaging. This leads to better drying results.

Packaging
Only ever use packaging materials and systems (sterile barrier systems) which comply with the standard
DIN EN ISO 11607-1. The correct use of suitable packaging is important in achieving successful steriliza-
tion results. You can use re-usable rigid packaging systems or soft packaging such as transparent sterili-
zation packaging, paper bags, sterilization paper, textiles or fibre web.

Closed sterilization containers

CAUTION
The use of unsuitable sterilization containers results in insufficient steam penetration
and even failure of the sterilization. This can also prevent condensate drain-off.
Consequences are poor drying results. This can result in unsterile instruments and thus
endanger the health of patient and practice team.

CAUTION
Incorrect stacking of the sterilization containers can result in the dripping condensate
being unable to drain off to the chamber floor. This can saturate sterilization material
directly underneath it.
Consequences are poor drying results. Ultimately, this can result in unsterile
instruments and thus endanger the health of patient and practice team.
n Do not cover the perforations when stacking the sterilization containers.

Comply with the following when using closed sterilization containers:


u Use aluminium sterilization containers. Aluminium retains and conducts heat and thus accelerates
drying.
u Closed sterilization containers must be either perforated or have a valve on at least one side. MELAG
sterilization containers (e.g. MELAstore Boxes) fulfil the requirements for successful sterilization and
drying.

22
6 Loading the steam sterilizer

u Wherever possible, please ensure that sterilization containers are only stacked on top of those of
identical size, so that the condensate can run down their sides.
u Ensure that the perforations are not covered when stacking the containers.
Tip: MELAG sterilization containers fulfil the requirements of DIN EN 868-8 for successful sterilization and
drying. They have a perforated lid and base and are fitted with disposable paper filters.

Soft sterilization packaging


Soft sterilization packaging can be used in both sterilization containers and on trays. Comply with the
following when using soft sterilization packaging e.g. MELAfol:
u Arrange soft sterilization packaging in a perpendicular position and at narrow intervals.
u Place transparent sterilization packages on their edge wherever possible and with the paper side
facing downwards.
u Do not place multiple soft sterilization packages flat on top of each other on a tray or in a container.
u If the seal seam tears during sterilization, the packaging could be too small or the sealing pulse too
low. Re-pack the instruments and if necessary, extend the sealing pulse on the film sealing device or
make a double seam. Sterilize the sterilization material again.

Multiple wrapping
The steam sterilizer works with a fractionated pre-vacuum procedure. This permits the use of multiple
wrapping.

Mixed loads
Please observe the following when sterilizing mixed loads:
u Always place textiles at the top.
u Place the sterilization containers at the bottom.
u Place unwrapped instruments at the bottom.
u Place the heaviest loads at the bottom.
u Place transparent sterilization packaging and paper bags at the top - except in combination with
textiles. In this case, place them at the bottom.

Load versions

Example:

Load versions*) Vacuklav 24 B+ Vacuklav 30 B+


Instruments Textiles Instruments Textiles
Max. weight per component 2 kg 2 kg 2 kg 2 kg
Maximum total weight 7 kg 2.5 kg 5 kg 2 kg
)
* MELAG mounts, trays, sterilization containers, see Accessories and spare parts [} page 60].
Loading patterns designed especially for the dental sector are available from the download area of the
MELAG website: www.melag.com and in the separate document “Usage instructions for mounts”.

23
7 Sterilization

7 Sterilization

Important information regarding routine operation


Please comply with the recommendations issued by the Robert Koch Institute (RKI) and the information
contained in DIN 58946-7.

Manufacturer's recommendation for the routine operation of type B steam sterilizers2)

When is it necessary to How should the checks be made?


make checks?
Once per working day ▪ Visual check of the door seal and the door lock for damage.
▪ Check the operating media (electricity, feed water and water connection
if necessary).
▪ Check the documentation media (printer paper / computer / network).
We recommend performing the steam penetration test with
MELAcontrol/MELAcontrol PRO in the Universal-Program (test
system in accordance with DIN EN 867-5).
Once a week ▪ Vacuum test
Tip: In the mornings before starting work - the steam sterilizer must
be cold and dry.
Batch-related tests With “Critical B” instruments:
▪ MELAcontrol/MELAcontrol PRO must be used as batch control with
every sterilization cycle.
With “Critical A” instruments:
▪ The process indicator (type 5 in accordance with DIN EN ISO 11140)
must be used as batch control with every sterilization cycle.
With “Critical A + B” instruments:
▪ MELAcontrol/MELAcontrol PRO must be used as batch control with
every sterilization cycle.
This simplifies the working procedure and increases security. You can
omit the daily steam penetration test with MELAcontrol/MELAcontrol PRO
(see above). The use of another test system in accordance with
DIN EN 867-5 is possible. The number of the available test systems
means that MELAG is not able to provide technical support when using a
different system.
The indicator test strips used need not be stored.

PLEASE NOTE
The results of the tests must be documented.

2)
in accordance with the current recommendations from the Robert Koch Institute

24
7 Sterilization

Selecting the program


You can switch between the initial state and the desired program using the program selection key 'P'.
Now select the sterilization program according to how and whether the sterilization material is wrapped. It
is also necessary to take into account the temperature resistance of the sterilization material.
The following table shows which program is to be selected for which sterilization material.

Overview of sterilization programs

Universal- Quick- Quick- Gentle- Prion-


Program Program B Program S Program Program
Sterilization 134 °C 134 °C 134 °C 121 °C 134 °C
temperature
Sterilization pressure 2.1 bar 2.1 bar 2.1 bar 1.1 bar 2.1 bar
Sterilization time 5:30 min 5:30 min 3:30 min 20:30 min 20:30 min
Operating time3) approx. 30 min approx. 30 min approx. 15 min approx. 40 min approx. 45 min
Drying approx. 20 min approx. 10 min approx. 5 min approx. 20 min approx. 20 min

Overview of the use of the respective sterilization programs

Program name Packaging Especially suitable for Load


24 B+ / 30 B+
Universal-Program Single and multiple Mixed load, long narrow- 7 kg / 5 kg
wrapping bore hollow bodies
Quick-Program B Single wrapped and Long narrow-bore hollow Single wrapped max. 1.5 kg
unwrapped bodies Unwrapped 7 kg / 5 kg
instruments (no
textiles)
Quick-Program S Only unwrapped (no Single massive 7 kg / 5 kg
textiles) instruments, simple hollow
bodies
Gentle-Program Single and multiple Textiles, thermo-unstable Textiles 2.5 kg / 2 kg
wrapped items (e.g. plastic, rubber Thermo-unstable
articles), mixed loads equipment 7 kg / 5 kg
Prion-Program Single and multiple Instruments under 7 kg / 5 kg
wrapped suspicion of carrying the
danger of infection through
abnormally altered proteins
(e.g. Creutzfeld-Jacob,
BSE)

3)
without drying, with a full load and dependent on the load and set-up conditions (e.g. cooling water temperature, if a
fixed water connection is present, and mains voltage)

25
7 Sterilization

Additional program options

Selecting automatic preheating


Automatic preheating is activated in delivery state.
If preheating is activated, the cold chamber is heated up to the preheating temperature of the particular
program before program start, or this temperature is held between two program runs. This reduces pro-
gram times and reduces the accretion of condensation, thus improving drying results.

PLEASE NOTE
The steam sterilizer must remain continually activated for the automatic preheating.
MELAG recommends activating the automatic preheating function.

To alter this setting proceed as follows:


1. Select Function by pressing the '+' and '-' keys simultaneously until the display
shows Function: Last batch number.
2. Navigate using the '+' or '-' key until the display shows:

Function:
autom. preheating

3. Press the 'P' key to confirm.


Ê The display will show the option currently set e.g. Preheating YES.
4. Pressing the 'P' key again makes the display switch to Preheating NO.
Ê The preheating function has been deactivated.
5. Press the 'S' key twice to leave Function: Autom. preheating and return to the initial state.

Selecting additional drying


The Additional drying function extends the drying time by 50 % to perform difficult drying tasks.
} Press the 'S' and '+' keys simultaneously upon program start.
The display will show:

Additional drying
selected

The program run will now begin.

26
7 Sterilization

Starting the program

NOTICE
Unsupervised operation of electrical devices, including this steam sterilizer at the
operator’s risk. MELAG accepts no liability what so ever for any damage resulting from
unsupervised operation.

After having selected a program via the program selection key 'P', the display will show both the selected
program and sterilization temperature as well as whether the program is suitable for wrapped or un-
wrapped sterilization material.

Universal-Program
134 °C wrapped

} Press the 'S' key to start the program.


The steam sterilizer checks the feed water supply and its conductivity.

PLEASE NOTE
If the Quick-Program S has been started, the warning Attention: Unwrapped
instruments only appears on the display.
If the load contains exclusively unwrapped instruments, press the 'S' key again to
confirm and to start the program.

Program run
After starting the program, you can follow the program run in the display. It shows the chamber
temperature and pressure as well as the time until the end of sterilization / the drying time which has
passed.

1. Fractionation
-0.085 bar 22 °C

Sterilization phase
The display enables you to see whether the sterilization phase has already been completed successfully.
The time left in the sterilization phase is shown in the display in alternation with the pressure and
temperature.

Sterilization
2 min, 12 s

Drying phase
The regular drying time for the Quick-Program S amounts to approx. 5 min. For the Quick-Program B ap-
prox. 10 min and for all other programs 20 min. The display will show the corresponding message during
the drying phase.

Vacuum drying
since 2' -0.12 bar 60 °C

27
7 Sterilization

The steam sterilizer provides excellent drying of the sterilization material. If difficult-to-dry items require
better drying, you can undertake the following steps to improve drying:
u Load the steam sterilizer properly. Stand e.g. the transparent and paper sterilization packaging
upright. Comply with the specifications of section Loading the steam sterilizer [} page 22]. Use the
optional package holder if necessary.
u Activate the Additional drying function. Comply with the specifications of section Additional
drying [} page 26].

Program end
When the program has been completed successfully, the display shows:

Universal-Program
run successfully

Working in the SETUP menu Function under Last batch number, if immediate output after program
end is activated, the log of the completed program will be outputted to the activated output medium after
opening the door, see Logging [} page 31].

Manual program abort


You can abort a current program in all phases. If you end a program before drying begins, the sterilization
material remains unsterile.

WARNING
Hot steam can be released from the device when opening the door after a program abort.
This could result in burns.
n Use a tray lifter to remove the tray.
n Never touch the sterilized equipment, the chamber or the door with bare hands. The
components are hot.

NOTICE
Aborting a running program by switching off the power switch can result in the egress of
hot steam from the sterile filter and will cause the soiling of the sterile filter.
n Never abort a program by switching off at the mains.

Program abort before the start of drying

WARNING
Danger of infection from early program abort
Aborting a program before the drying phase begins means that the load is unsterile. This
endangers the health of your patients and practice team.
n If necessary, repack the load and repeat the sterilization for the sterilization material
affected.

28
7 Sterilization

Proceed as follows to abort the program during drying:


1. Press the 'S' key.
2. Confirm the following security query Stop program? by pressing the 'S' key repeatedly.

PLEASE NOTE
The security query will be displayed for approx. five seconds. If the 'S' key is not pressed
again, the program will continue with the usual program run.

Depending on the time of the abort, pressure will be released or the device will be ventilated. A corres-
ponding display text appears on the display.
After pressure release or ventilation, you will be asked to acknowledge the program abort.
The display will alternate between Stop / End and Acknowledge with '-' key.
3. Press the '-' key.
Ê The display will alternate between Unlock door with '+' key and the program previously
selected.
4. You can open the door after pressing the '+' key.
Ê The log will contain: Program stopped / Load not sterile!

Program abort after the start of drying


You can abort the program during the drying phase via the 'S' key without the steam sterilizer registering a
fault.
Should you abort a program after drying has started, the sterilization is having been completed
successfully. The steam sterilizer will not issue a malfunction message. You should expect insufficient
drying, especially in the case of wrapped sterilized equipment and a full load. Sterile storage requires
sufficient drying. To ensure this, please allow programs with wrapped sterilized equipment to continue to
the end of the drying phase as far as is possible. Unwrapped instruments sterilized in a Quick-Program dry
after being removed from their own warmth.
The drying time completed thus far is indicated on the display during the drying phase. This will alternate
with the display of:

Immediate removal
press 'Stop'

Proceed as follows to abort the program during drying:


1. Press the 'S' key.

PLEASE NOTE
The security query will be displayed for approx. five seconds. If the 'S' key is not pressed
repeatedly, the program will continue with the usual program run.

2. Confirm the following security query Immediate removal 'Stop' by pressing the 'S' key again.
Ê The display confirms the abort with Drying stopped.
After ventilation of the chamber, the display will show: Universal-Program run successfully in
alternation with:

Last batch no. 46


Quit with button '+'

If a printer or other output medium is connected to the steam sterilizer, and Immediate output is set
to YES, the warning Drying stopped is recorded on the log.

29
7 Sterilization

Removing the sterilized equipment

CAUTION
Danger of burns from hot metal surfaces
n Allow the device to cool sufficiently before opening.
n Do not touch any hot metal parts.

CAUTION
Unsterile instruments resulting from damaged or burst packaging. This endangers the
health of your patients and practice team.
n Should the packaging be damaged or have burst, re-pack the sterilization material and re-
sterilize it.

If you remove the sterilized equipment from the device directly after the end of the program, it is possible
that the instruments can be partially damp. According to the red broschure of the Arbeitskreis für Instru-
mentenaufbereitung (AKI), the tolerable residual moisture is - in practice - a few drops of water capable of
evaporating within 15 min, but actual pools of water are not acceptable.
Comply with the following specifications when removing the sterilized equipment:
u Never use force to open the door. This could damage the device or result in the emission of hot
steam.
u Use a tray lifter to remove the tray.
u Never touch the sterilized equipment, the device interior or the inside of the the door with unprotected
hands. The components are hot.
u Check the packaging on the sterilized equipment for damage when removing it from the device.
Should the packaging be damaged, re-pack the sterilization material and re-sterilize it.

Storing sterile instruments


The maximum storage time is dependent on the packaging and the storage conditions. For standard-
conform packaged sterilized equipment – (if protected from dust) it can amount to up to six months.
Comply with the provisions of DIN 58953, part 8 and the criteria specified below for the storage of
sterilized equipment:
u Comply with the maximum storage duration in accordance with the packaging type.
u Do not store the sterilized equipment in the decontamination room.
u Store the sterilized equipment in a dust-protected environment e.g. in a closed instrument cabinet.
u Store the sterilized equipment in an environment protected against moisture.
u Store the sterilized equipment in an environment protected against excess temperature variations.

30
8 Logging

8 Logging

Batch documentation
The batch documentation serves as proof of the successful conclusion of the program and represents an
obligatory part of quality assurance (MPBetreibV). The device internal log memory saves such data as the
program type, batch and process parameters of all the programs completed.
To obtain the batch documentation, you can output the internal log memory and transfer its data to various
output media. This can be performed immediately at the end of every program or at a later point, such as
at the end of the day.

Capacity of the internal log memory


The capacity of the internal log memory is sufficient for 40 logs. If the internal log memory is full, the oldest
log will be overwritten automatically at the beginning of the next program.
If a printer is connected and the option Immediate output has been set to NO, a security query will be
issued before the saved log is overwritten. For further information about connecting the printer, consult the
operating manual of the respective device.

Displaying the daily batch counter


The last batch number of the day is shown on the display after every program run.

Last batch no.


10

You can also arrange for the batch number to be displayed. To do so:
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will
show Function: Last batch number.
2. Press the 'P' key to display the current daily batch number.
3. To return to the initial state, press the 'S' key twice.

Displaying the total batch counter


You can arrange the display of the number of the batches previously run.
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will
show Function: Last batch number.
2. Navigate using the '+' or '-' keys until the display shows:

Total batch
22

3. Press the 'P' key to display the current total batches counter.
4. To return to the initial state, press the 'S' key twice.

31
8 Logging

Output media
You are able to output and archive the logs of the completed programs on the following output media:
▪ MELAflash CF card printer on the CF card
▪ Computer, e.g. with MELAtrace/MELAview software (optionally with MELAnet Box)
▪ MELAprint 42/44 log printer
In its delivery state, an option for log output is not set on the steam sterilizer.

PLEASE NOTE
Further information about the log printer (e.g. the duration of the readability of the log
printouts) is specified in the appendant user manual.

Using a computer as an output medium (without a network connection)


In order to be able to use a computer as an output medium, the computer must be connected to the steam
sterilizer via the serial interface.
You can connect the steam sterilizer to a computer if the following conditions are fulfilled:

ü The computer is either fitted with a serial interface or a USB serial adapter is connected.
ü The documentation software MELAview/MELAtrace is installed on the computer.

PLEASE NOTE
The MELAnet Box is required for integration in the (practice) network.

1. Open the door of the steam sterilizer.


2. Open the white cover of the serial data and printer connection on the steam sterilizer. Turn the sealing
slot on the white cover (pos. 2) a quarter revolution using a coin.
3. Remove the cover.
4. Push the metal frame (pos. 4) downwards slightly until it unlocks and then fold the metal frame
forwards.
5. Push the metal frame downwards slightly until it snaps into place and can no longer fold back
independently.
6. Connect the steam sterilizer from the RS232 interface (pos. 1) to the computer with a suitable data
connection cable.

PLEASE NOTE
If the computer is constantly connected to the steam sterilizer, you can insert the serial
cable in the cable duct (pos. 3) fold in the metal strap and replace the cover.

1 2 3 4
Fig. 4: Connection on the steam sterilizer

32
8 Logging

Reading out text logs on the computer


You can use the MELAtrace/MELAview software to read out the logs.
The following settings are required to register the computer on the steam sterilizer:
1. Switch on the steam sterilizer.
Wait until the display shows the initial state.
2. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will show
Function: Last batch number.
3. Navigate with the '+' or '-' keys in the Function menu until the display shows Function: Log
output.
4. Press the 'P' key to select the Log output – Output medium submenu.
5. Press the 'P' key again. If an output medium has yet to be chosen, the display will show the Log
output – No output medium notification.
Navigate using the '+' or '-' keys until the display shows:

Output medium
Computer

6. Press the 'P' key to confirm. The display switches back into the Log output – Output medium
menu.
7. Press the 'S' key to return to the SETUP menu Function: Log output.
8. After repeated pressing of the 'S' key, the display returns to its initial state.

Opening text logs on the computer


All text logs can be opened and printed using a text editor, a word processing program or a spreadsheet
program.

PLEASE NOTE
Graphic logs cab only be displayed with the MELAtrace / MELAview (from MELAview 3)
documentation software.

Each text log (e.g. .PRO, .STR, .STB etc.) must be linked with the text editor to enable the operating sys-
tem of your computer to open them automatically with a text editor. The meanings of the endings are out-
lined in the section Subsequent log output [} page 35]. The following examples show how you can link
the Windows 10 editor with a specific text log.
1. Working in Windows Explorer, double click on the
log file.

2. If the file ending is unfamiliar, Windows 10 will display


the following message:

3. Select Try an app on this PC.

33
8 Logging

4. Mark the editor and confirm with "OK".

Ê You can then open files with this ending via a double-click in Windows Editor.
Alternatively, you can open all text logs with the documentation software MELAtrace / MELAview (from
MELAview 3).

Outputting logs immediately and automatically


Text logs
If you want to output the associated text log on an output medium automatically and immediately after the
end of a program, use the following function: Immediate output YES. This is not set in the delivery
state.
The following requirements must be fulfilled in order to output logs immediately after the end of a program:

ü Working in SETUP menu Function: Log output, immediate output is set to YES.
ü At least one output medium must be selected (computer, MELAprint 42/44 log printer).
ü The activated output medium must be connected and initialized.

1. Switch on the steam sterilizer at the power switch.


2. Select SETUP menu Function by pressing the '+' and '-' key simultaneously.
The display will show the message Function: Last batch number.
3. Navigate using the '+' or '-' key until the display shows: Function: Log output and press the 'P'
key.
4. Navigate using the '+' or '-' key until the display shows:

Immediate output
YES

5. Press the 'P' key to change between: Immediate output NO or YES.


6. Press the 'S' key to save the setting and to leave the menu. The display will show the
message Function: Log output.
7. Pressing the 'S' key once again enables you to leave the menu and return to the display initial state.

34
8 Logging

PLEASE NOTE
If immediate output is unable to output a log, for example, because the output medium
activated is not connected, a warning will appear. MELAG recommends using the
immediate log output function.

For log output immediately after program end, comply with the following:
u In SETUP menu Function: Log output MELAnet+graphic data must be selected as the output
medium.
u The computer or another medium must be connected and initialized.

Subsequent log output


It is possible to issue logs subsequently and independently of the time of a program end. You can choose
whether all or only the saved logs (up to 40) are to be printed. Use the output media connected for this
task e.g. the log printer.

Printing selected logs


To print the subsequently selected logs of a particular program proceed as follows:
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will show
the notification Function: Last batch number.
2. Navigate using the '+' or '-' keys until the display shows Function: Log output and press the 'P'
key.
The Log output – Output medium menu will be displayed.
3. Navigate using the '+' or '-' keys until the display shows: Last cycle output: no. 40 (as example
no. 40).
4. Press the 'P' key. The current log number flashes.
5. To issue a log or another cycle, navigate to the desired number using the '+' or '-' keys until you have
reached the desired number. In this example 25.
6. Press the 'P' key in order to start the output of the selected program. The display will show Output.
After a successful output, the display returns to its previous setting and shows:

Last cycle
output: 25

Repeat the last three steps in order to output further logs.


7. Press the 'S' key to leave the submenu without outputting the log.
8. Press the 'S' key to leave the menu after having outputted the log. The display will
show Function: Log output.
9. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display
initial state.

Outputting all saved logs


Proceed as follows to output all the saved logs subsequently:
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously.
The display will show the notification Function: Last batch number.
2. Navigate using the '+' or '-' keys until the display shows Function: Log output and press the 'P'
key.

35
8 Logging

3. Navigate using the '+' or '-' keys until the display shows:

Output
stored cycles

4. Press the 'P' key in order to start the output of the selected program. Once the issue has been
performed, the display will show: Output.
Ê If output has been performed, the display will again show: Output stored cycles.
5. Press the 'S' key to leave the submenu without outputting the log.

PLEASE NOTE
An abort during log output on the log printer is only possible during deactivation of the
device using the power switch or by interrupting the power supply to the printer.
When switching off the device via the power switch, wait three seconds before switching
it back on.

6. Press the 'S' key to leave the menu. The display will show SETUP menu Function: Log output.
7. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display
initial state.

Displaying the log memory


If a printer or other output medium is connected and initialized, you can check how many logs have
already been saved in the steam sterilizer log memory.
Proceed as follows:
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will
show Function: Last batch number.
2. Navigate using the '+' or '-' keys until the display shows: Function: Log output and press the 'P'
key.
3. Navigate using the '+' or '-' keys until the display shows the number of logs saved:

Allocated: 26
Free: 14

4. Press the 'S' key twice to leave the menu.

Deleting logs in the internal log memory


Delete the saved logs manually to suppress the warning Protocol memory full with the option
Immediate output NO set. The following example shows how to delete all the logs saved.
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will show
Function: Last batch number.
2. Navigate using the '+' or '-' keys until the display shows: Function: Log output and press the 'P'
key.
3. Navigate using the '+' or '-' keys until the display shows:

Delete
all cycles

4. Press the 'P' key to delete all logs.

36
8 Logging

5. To cancel the submenu without deleting, press the 'S' key.


6. Press the 'P' key to leave the menu after deletion. The display will show Function: Log output.
7. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display
basic state.

Reading logs correctly


Log type File ending Explanation
Text log .PRO Log of a successfully completed program
Malfunction log .STR Log of an unsuccessfully completed program
Graphic log .GPD Program run displayed as a graphic curve
Standby log .STB Log for malfunctions in standby
Demo log .DEM Log of a simulated program run
No real sterilization will be performed!
Demo graphic log .DEG The simulated program run will be displayed as a graphic
curve
No real sterilization will be performed!

Log header
The header of the program log comprises the general basic information regarding the program run. This
includes e.g. date, the selected program, the daily batch number and the steam sterilizer type.

Program step values


The phases of the program run together with the values for steam pressure, temperature and time (related
to the program start) are recorded whilst it runs.

Summary
The summary states whether the program has been completed successfully. The values of the sterilization
time required, the sterilization temperature and the pressure (including the maximum deviation) are also
displayed.

37
8 Logging

------------------------------------------ ----------------------------------------------------------
MELAG Vacuklav 24-B Steam sterilizer type
------------------------------------------ ----------------------------------------------------------
Program : Universal program
134°C Packaged
Program started
Date : 27.03.2015 Current date
Time of day : 08:36:39 (Start) Time upon program start
Batch number: 10 Daily batch number
SN : 201524-B1150 Serial number
----------------------------------------------------------
Preheating 81.2 °C
AIN6: Conductivity 7 µS/ cm Preheating temperature
Feed water conductivity

Start 0.00 25.2 00:00


1.Fractionation
Evacuation -0.92 22.6 01:02
Steam entry 0.40 106.8 05:50
2.Fractionation VALUES OF THE PROGRAM STEPS
Evacuation -0.82 58.5 07:25
Steam entry 0.40 109.5 09:32
3.Fractionation
Evacuation -0.82 61.4 11:14
Steam entry 0.40 109.4 13:15
Heat up 2.05 134.2 15:51
Steriliz.begin. 2.05 134.2 15:51
Steriliz.end 2.16 135.7 21:21
Press. release 0.17 106.1 21:47
Vacuum-drying Program run phases with the appendant values for
Drying begin. -0.31 92.4 21:58
pressure, temperature and time (relative to the program
Drying pressure -0.92 92.6 23:56
Drying pressure -0.93 91.2 25:56 start)
Drying pressure -0.93 86.5 27:56
Drying pressure -0.93 82.0 29:56
Drying pressure -0.94 78.6 31:56
Drying pressure -0.94 76.2 33:56
Drying pressure -0.93 74.4 35:56
Drying pressure -0.93 73.3 37:56
Drying pressure -0.93 72.4 39:56
Drying pressure -0.93 71.6 41:56
Drying end -0.87 71.7 41:58
Ventilate -0.30 73.3 42:12
End 0.00 74.3 42:26

------------------------------------------ ----------------------------------------------------------
SUMMARY - Control notification
Program properly executed!
Median sterilization temperature with max. deviations
Temperature : 135.8 +0.4 /-0.3 °C Median sterilization pressure with max. deviations
Pressure : 2.17 +0.03/-0.03 bar Sterilization time maintained
Sterilizate time: 5 min 30 s Time upon program end
Time of day : 09:19:06 (End)
==========================================
----------------------------------------------------------
26 201501150 5.15 5.05 Information with total batch counter, factory number and
device software number / version no.
Fig. 5: Example for a text log of a successfully completed program.

38
9 Function tests

9 Function tests

Automatic functional checks


The electronic parameter control subjects the interaction of the sterilization-relevant parameters pressure,
temperature and time to constant automatic monitoring. The steam sterilizer process evaluation system
compares the process parameters during the program with each other and monitors them in terms of their
threshold values. The steam sterilizer monitoring system checks the device components for their
functionality and their plausible interaction. Should the parameters exceed pre-set threshold values, the
steam sterilizer emits warning messages or malfunction messages. If necessary, it interrupts the program
with appropriate information. When the program has ended successfully, the corresponding message will
be issued on the display.

Manual functional checks


You can follow the program run on the display via the values displayed there. You can also use the log re-
corded for every program to determine its success, see Logging [} page 31].

Batch-related tests
Helix test body system MELAcontrol / MELAcontrol PRO
The Helix test body system MELAcontrol is an indicator and batch control system fulfilling the requirements
of DIN EN 867-5. It consists of a test body, the Helix and an indicator strip.
When sterilizing category “critical B“ instruments, you should add the MELAcontrol / MELAcontrol PRO test
body to every sterilization cycle as a batch control.
Regardless of this, you can perform a steam penetration test in the Universal-Program at any time using
MELAcontrol / MELAcontrol PRO.
Intended use of the Helix test body can result in the colouration of the plastic surface. This colouration
exercises no influence on the functionality of the Helix test body.

Vacuum test
The test detects leaks in the steam sterilizer. This determines the leakage rate at the same time.
Perform a vacuum test in the following circumstances:
▪ Once a week in routine operation
▪ During commissioning
▪ Following longer operating pauses
▪ In the case of a corresponding malfunction (e.g. in the vacuum system)
Perform the vacuum test with the steam sterilizer in a cold and dry state as follows:
1. Switch on the device at the power switch. The display switches to its initial state.
2. Press the 'P' key until the display shows Vacuum test.
3. Close the door.
4. Press the 'S' key to start the vacuum test.
Ê The evacuation pressure and the equilibration time or measuring time are shown on the display. The
chamber is ventilated after the end of the measuring time. Then the message will be shown on the
display with an indication of the leakage rate. Should the leakage rate be too high i. e over 1.3 mbar, a
corresponding message will be issued on the display.

39
9 Function tests

The current daily batch number and Acknow. with '+' key is displayed. You can open the door after
pressing the '+' key.

PLEASE NOTE
If a log printer or another output medium is connected and the setting Immediate
output YES is set, a log printout will be issued at the same time.

Bowie & Dick test


The Bowie & Dick test serves as proof of steam penetration of porous materials such as e.g. textiles.
Specialist stockists provide various test systems for the Bowie & Dick test. Perform the test according to
the test system manufacturer information.

Bowie & Dick test


134°C 2.2 bar 3.5'

How to start the Bowie & Dick test program:


1. Switch on the device at the power switch.
2. Select the Bowie & Dick test by pressing the 'P' key repeatedly.
3. Press the 'S' key to start the Bowie & Dick test.
Following a successful test program, the current daily batch number is displayed, alternating with Acknow.
with '+' key. You can open the door after pressing the '+' key.

PLEASE NOTE
If a log printer or another output medium is connected and the setting Immediate
output YES is set, a log printout will be issued at the same time.

PLEASE NOTE
Treatment indicator strips often exhibit differing intensities in the colour change
indicating a different length of storage of the manufacturer batches or other influences.
Of crucial importance for evaluating the Bowie & Dick test is not the strength of contrast
in the colour change on the test sheet, but its even nature.
If the treatment strips/treatment indicator sheet indicates an equal distribution of colour
change, the venting of the sterilization chamber is without fault.
If the treatment indicator strips or the treatment indicator sheets are uncoloured or
exhibit less colour in the centre of the star in comparison to the end, venting was
insufficient. In this case, contact the authorized customer services / stockist technician.

Checking the quality of the feed water


You can access the water quality on the display at any time during a current program when the steam
sterilizer is switched on.

AIN6: Conductivity
15 µS/cm

} To do so, hold the '-' key depressed until the display shows Conductivity.
Ê The conductivity is displayed in µS/cm.
Ê As soon as you have released the '-' key, the display returns to its previous state (e.g. initial state).

40
9 Function tests

Checking the preheating temperature of the chamber


} Press the '-' key twice. When pressing the first time, press shortly. When pressing the second time,
hold the key depressed.

AIN4: Temp. preheat.


120°C

Ê The conductivity display disappears and the preheating temperature in the chamber will be
displayed.

41
10 Maintenance

10 Maintenance

Servicing intervals
Interval Measure Device components
Daily Check for soiling, deposits or Chamber inc. door seal and chamber
damage sealing face, door lock, mount for the load
After 24 months or Maintenance By the authorized customer services
1000 cycles working in accordance with the
maintenance instructions
As required Cleaning the surfaces Housing parts

Cleaning

NOTICE
Inappropriately performed cleaning can lead to the scratching of and damage to surfaces
and the development of leaks in sealing surfaces.
This also favours the development of soiling deposits and corrosion in the sterilization
chamber.
n Comply with all information regarding cleaning of the part affected.

Door seal, chamber, chamber sealing face, mount, trays


Check the chamber, chamber sealing face, the door seal and the mount for the load weekly for soiling,
deposits or damage.
If you find any impurities, remove the trays, cassettes and mount from the chamber from the front. Clean
the soiled components and the chamber.
When cleaning the chamber, load mount and chamber seal face and door seal, please comply with the
following:
u Switch off the steam sterilizer before cleaning and remove the power plug from the socket.
u Ensure that the chamber is not hot.
u Use a soft, non-fuzzing cloth.
u First soak the cloth in the cleaning alcohol or spirit and attempt to wipe away impurities.
u Use a chlorine and vinegar-free cleaning fluid.
u Only if the chamber, mount or chamber sealing face has persistent soiling should you use a mild, non-
scouring, stainless steel cleaning agent, with a pH value between 5 and 8.
u Use a neutral liquid cleaning agent to clean the door seal.
u You should not allow cleaning fluid to enter the piping coming from the chamber.
u Do not use any hard objects such as a metal saucepan cleaner or a steel brush.

Housing parts
Where necessary, clean the housing parts with a neutral fluid cleaner or spirit.

42
10 Maintenance

External water storage container


Should you use the external water storage container for the feed water supply, perform regular checks and
cleaning as follows:

Interval
Upon every refill Check the storage container for soiling. Clean any soiling before refilling
the storage container.
At least once a month Depending on the light, ambient temperature and consumption, clean the
external water storage container to prevent the development of germs
and algae. To do so, empty the container and clean it with approx. 3 l of
warm tap water with a neutral cleaning agent and a suitable brush. Rinse
with a large quantity of tap water at least twice. Always rinse the storage
container with a litre of feed water after completing the cleaning.

Avoiding staining
Only proper cleaning of the instruments prior to sterilization enables you to avoid residue from being
released from the load under steam pressure during sterilization. Loosened dirt residue can clog the filter,
nozzles and valves of the steam sterilizer and deposit themselves on the instruments and chamber as
deposits and stains.
All steam-conducting parts of the steam sterilizer consist of non-rusting material. This rules out the
possibility of stain or rust development being caused by the steam sterilizer. Any rust which develops is
always extraneous rust.
Incorrect instrument decontamination can result in the accretion of rust even on stainless steel instruments
of leading manufacturers. Often, an instrument which drops rust can suffice to cause the development of
rust on another instrument or in the steam sterilizer. Remove extraneous rust from the instruments using a
chlorine-free stainless steel cleaning agent (see the Cleaning [} page 42] section) or send the damaged in-
struments to the manufacturer for treatment.
The extent of stain accretion on the instruments is also dependant on the feed water used for steam
generation.

Replacing the door seal


The door seal may not be greased or oiled. It should be kept clean and dry. If the door seal becomes worn
or looses form, it must be replaced. Otherwise, this could result in leaks which will enable steam egress, or
can cause too high a leakage rate in the vacuum test. The door seal is only inserted in the groove of the
round blank and can be changed as follows:

1. Open the steam sterilizer door and remove the old


door seal.

43
10 Maintenance

2. Insert the door seal in the groove of the round blank.

PLEASE NOTE
Make sure that the broad seal face faces the chamber. The door can only be shut
correctly and the chamber sealed, if the door seal sits correctly in the groove.

Replacing or sterilizing the sterile filter


The sterile filter must be replaced regularly within the scope of the maintenance. Given the incidence of a
malfunction and the malfunction message F32: Power failure / Sterilize sterile filter
replace or sterilize the sterile filter.

NOTICE
Only ever operate the steam sterilizer with a sterile filter inserted.

Replacing the sterile filter

1. Remove the sterile filter by turning and pulling it from


the holding sockets simultaneously.

44
10 Maintenance

2. Replace the sterile filter or sterilize the current


sterile filter, see Sterilizing the sterile filter
[} page 45].

3. Exert a little pressure on the sterile filter and turn to


insert it into the holding sockets.

Sterilizing the sterile filter

1. Remove the sterile filter by turning and pulling it from


the holding sockets simultaneously.

2. Slide a into the steam sterilizer and place the sterile


filter vertically on the tray. Ensure that the sterile filter
does not fall over, otherwise the condensate will not
be able to drain away correctly.

3. Start the Gentle-Program.

4. Remove the sterile filter from the device after the


program end and allow it to cool for min.
15 minutes.

5. Exert a little pressure on the sterile filter and turn to


insert it into the holding sockets.

45
10 Maintenance

Cleaning the filter in the chamber


1. Screw out the condensate return filter (pos. a) and the
chamber filter (pos. b) anti-clockwise from the opening
in order to perform a check.

Unscrew the chamber filter (pos. b) using the chamber a


filter wrench included in the scope of delivery (pos. c).

2. Rinse the filter (a and b) for cleaning with water.

3. Screw in the condensate return filter (pos. a) and


the chamber filter (pos. b) clockwise into the
opening.

Maintenance

NOTICE
Continuing operation beyond the maintenance interval can result in malfunctions in the
device.
n Maintenance should only be performed by trained and authorized service technicians or
stockist technicians.
n Maintain the specified servicing intervals.

Regular maintenance is vital to ensure reliable operation and value retention of the steam sterilizer. All
function and safety-relevant components and electrical units must be checked during maintenance and
replaced where necessary. Maintenance is performed in accordance with the maintenance instructions
pertinent to this steam sterilizer.
Arrange for regular maintenance in 24 months intervals or after 1000 program cycles. The steam sterilizer
will issue a maintenance message at the relevant time.

46
11 Pause times

11 Pause times

Frequency of sterilization
Pause times between individual programs are not necessary. After the end/abort of the drying time and
removal of the sterilized equipment, you can load the steam sterilizer again and start a new program.

Operating pauses
Depending on the duration of the operating pauses, the following measures must be maintained:

Duration of the operating pause Measure


Short pauses between two sterilization ▪ Keep the door closed to save energy
processes
Pauses which last longer than an hour ▪ Switch off the steam sterilizer
Longer pauses e.g. over night or the ▪ Switch off the steam sterilizer
weekend ▪ Leave the door ajar to prevent premature wear and the
sticking of the door seal
▪ Shut off the cooling water inflow and if present, the water
inflow to the water treatment unit
Longer than two weeks ▪ Switch off the steam sterilizer
▪ Leave the door ajar to prevent premature wear and the
sticking of the door seal
▪ Shut off the cooling water inflow and if present, the water
inflow to the water treatment unit
Upon re-commissioning:
▪ Perform a vacuum test
▪ After a successful vacuum test, perform an empty
sterilization run in Quick-Program B
After pauses, perform the checks described in chapter Function tests [} page 39] depending on the length
of pause.

Decommissioning
When decommissioning the steam sterilizer for a long pause (e.g. due to holiday or planned transport),
proceed as follows:
1. Switch off the steam sterilizer at the power switch.
2. Disconnect the power plug from the socket.
3. Clean the storage container if present.
4. Close the water inflow if you are using a water treatment unit.

PLEASE NOTE
Comply with the specifications of the technical manual when transporting. The manual
contains detailed instructions.

Recommissioning after relocation


When recommissioning after a move, proceed as with the first commissioning; see the technical manual.

47
12 Malfunctions

12 Malfunctions

Warnings
Warnings are not malfunction messages. They help to ensure malfunction-free operation and to recognize
undesirable situations. Comply with these warnings early in order to avoid malfunctions.

Malfunction messages
Malfunction messages are issued on the display with an event number. This number serves identification
purposes. Malfunction messages are issued when it is not possible to ensure safe operation or safety of
sterilization. These can appear on the display shortly after activating the steam sterilizer or during a pro-
gram run.
If a malfunction occurs during a program run, the program will be aborted.

WARNING
Danger of infection from early program abort
Aborting a program before the drying phase begins means that the load is unsterile. This
endangers the health of your patients and practice team.
n If necessary, repack the load and repeat the sterilization for the sterilization material
affected.

Before contacting customer services


Ensure that you have complied with all instructions relating to a warning or malfunction message issued by
the display of the device. The following table contains a summary of the most important events. The
events contain possible causes and the corresponding operator information.
Should the following table not contain the relevant event, or your efforts do not redress the problem, you
can contact your nearest stockist or a local authorized MELAG customer service provider. Have your de-
vice serial number and a detailed description of the malfunction contained in the notification to hand.

General events
Incident Possible causes What you can do
Empty display Insufficient power supply. Check the power plug for its correct
position in the socket.
Check the mains voltage at the socket.
If necessary, replace the device fuses on
the lower front the steam sterilizer, see
Replacing the device fuses [} page 58].
Door cannot be The door seal sticks to the seal face. 1. Switch on the steam sterilizer.
opened 2. Press the '+' key to open the door and
pull strongly on the door in order to
open it.
Feed water The steam sterilizer has been Comply with the load quantities, see
consumption too high loaded incorrectly. Loading the steam sterilizer [} page 21].
The steam sterilizer has not been Check that the steam sterilizer is set up
set-up correctly. correctly. If necessary, increase the slope
of the device feet by unscrewing them by
max. two revolutions.
Condensate reflux is prevented. Remove any instruments, filter paper or
other objects which have fallen onto the
chamber floor.

48
12 Malfunctions

Incident Possible causes What you can do


Poor drying results The steam sterilizer has been Comply with the load quantities, see
loaded incorrectly. Loading the steam sterilizer [} page 21].
The textiles must not be permitted to have
direct contact with the chamber wall and
floor.
The steam sterilizer has not been Check that the steam sterilizer is set up
set-up correctly. correctly. If necessary, increase the slope
of the device feet by unscrewing them by
max. two revolutions.
Condensate reflux is prevented or Remove any instruments, filter paper or
blocked. other objects which have fallen onto the
chamber floor. Check the chamber filter
and condensate reflux filter for blockage.
Activate preheating.
Select automatic preheating, see Selecting
automatic preheating [} page 26].
Activate additional drying, see Selecting
additional drying [} page 26].

Warnings
Incident Possible causes What you can do
Notice: no feed water/ When using the external water storage container:
check the feed water There is too little or no water in the Check the cooling filling level and refill if
inflow storage container. necessary.
The inflow hose is kinked. Check for the kink-free installation of the
inflow hose.
The suction left is too high (max. Check the position of the suction fittings on
suction lift 1.5 m from the floor of the the floor of the storage container.
external water storage container to
the suction fittings of the steam
sterilizer).
When using a MELAG water treatment unit:
The suction filter of the external Clean the suction filter.
water storage container is blocked.
The warning will be displayed after a MELAdem 40/53/53 C:
program start. The installed flow Check the water treatment unit and open
monitor does not close. the inflow to the system if necessary. Upon
repeated incidence, contact an authorized
customer services / stockist technician.
MELAdem 47:
Check the water treatment unit and if
necessary, open the inflow to the system.
Perform a new start with an empty
pressure storage after approx. one hour.
Upon repeated incidence, contact an
authorized customer services / stockist
technician.
PLEASE NOTE: This message can be
issued following commissioning /
recommissioning, as the pipe system is still
empty. Repeat the start.

49
12 Malfunctions

Incident Possible causes What you can do


Notice: no cooling The water inflow tap is not open. Check the cooling water inflow and open
water / check the tap the water inflow tap if necessary.
water The water pressure in the building is Check the cooling water pressure
too low. (increase the pressure e.g. domestic water
supply).
The motor protection switch has Press the motor protection switch reset
tripped. button back in, see Views of the device
[} page 14].
The vacuum pump is stuck after a Actuate the vacuum pump manually, see
long stoppage. technical manual.
Poor feed water / The conductivity of the feed water is Start through repeated pressing of the 'S'
replace the cartridge too high. key still possible.
or module When using the external water storage container:
Conductivity ≥ 40 µS/cm 1. Empty and clean the container.
2. Rinse the container with fresh feed
water and fill it with water of a quality
stipulated by DIN EN 13060.
When using a MELAG water treatment unit:
The mixed-bed resin is exhausted. MELAdem 40/53/53 C:
Replace the mixed-bed resin (art. no.
61026), see the user manual of the
MELAdem 40 water treatment unit.
The mixed-bed resin in the ion MELAdem 47:
exchanger (3. cartridge) is Replace the mixed-bed resin (art. no.
exhausted. 37470), see the user manual of the
MELAdem 47 water treatment unit and
check the treatment unit.
Following repeated incidence, arrange for
maintenance to be performed by the
authorized customer services / stockist
technician. The pre-filter and activated
carbon filter may require changing.
When using a different water treatment unit:
The mixed-bed resin in the reverse Replace the module / resin cartridge in
osmosis unit is exhausted. accordance with the manufacturer's
operating instructions. Maintenance is
required following repeated incidence.
PLEASE NOTE: Perform a program start
after completing the work outlined above.
This warning can be issued upon the initial
start after maintenance of the water
treatment unit, as the inflow hose / the
measurement cell have not been
completely rinsed with fresh water.
Insufficient quality of Feed water conductivity too high. Start no longer possible.
feed water / start not Conductivity ≥ 65 µS/cm See incident: Poor feed water / replace the
possible cartridge or module.
Please wait, the This display appears during the The steam sterilizer starts automatically
chamber is warming program start phase. The steam after the starting temperature has been
sterilizer has not yet reached the reached.
starting temperature.
Notice: change the The min./max. pressure is Replace the sterile filter.
sterile filter exceeded/undercut during air drying; PLEASE NOTE: The message comes at
the sterile filter is soiled or torn. the end of the program and in the last line
of the log output.

50
12 Malfunctions

Incident Possible causes What you can do


Output medium is not The steam sterilizer is operating Working in the Log output menu, set
ready without an output medium, but one the option No output medium.
has been registered.
The output medium has not been Check that the data cable has been
connected properly. connected to the steam sterilizer and
output medium correctly.
The electricity supply to the printer Make sure that the power supply is
has been interrupted. connected. The red LED “P” on the
MELAprint 42/44 log printer must illuminate
red.
The printer is offline. Set the printer online (press the 'SEL' key
on MELAprint 42/44, the “SEL” LED must
illuminate green).
Log memory full The internal log memory of the The message is displayed upon program
device is full (max. 40 logs possible). start.
Repeated pressing of the 'S' key removes
the message and the program starts. The
oldest log will be deleted in the process.
An output medium has been 1. Set the steam sterilizer to Immediate
registered. In the Log output output YES, see Outputting logs im-
menu, the option Immediate mediately and automatically
output NO has been set. [} page 34].
2. Delete the internal device memory,
see Deleting logs in the internal log
memory [} page 36]. If necessary, out-
put all previously saved logs, see Sub-
sequent log output [} page 35].
3. Working in the Log output menu,
deselect the output medium and set
the option No output medium.
Carry out The maintenance message is The message is displayed upon every
maintenance activated. The device has reached program start.
the set number of batches or the Repeated pressing of the 'S' key removes
running time of 24 months. the message and the program starts.
Retain the message: Press the 'S' key
twice to start.
Arrange for maintenance by the authorized
customer services / stockist technician.
PLEASE NOTE: The maintenance counter
is reset by the customer services.
Test unsuccessful The leakage rate determined during 1. Check the door seal and the chamber
Leakage rate: 3.2 the vacuum test lies over the flange for soiling and clean if
maximum permissible value of necessary.
1.3 mbar. 2. Check the door seal for damage and
The door seal and/or chamber change if necessary, see Replacing
flange is soiled. the door seal [} page 43].
3. Repeat the vacuum test with a cold de-
vice, see Vacuum test [} page 39].
The door seal has been inserted 1. Check the door seal for its correct po-
incorrectly. sition.
2. Repeat the vacuum test with a cold de-
vice, see Vacuum test [} page 39].
Notice! Battery empty Monitoring of the internal battery The battery is to be replaced by the
voltage has returned a low value. authorized customer services / stockist
technician.

51
12 Malfunctions

Malfunction messages
Incident Possible causes What you can do
F02 The steam sterilizer is overloaded. Comply with the maximum permissible load
quantities, see Loading the steam sterilizer
[} page 21].
The incline to the steam sterilizer is too Check the incline of the steam sterilizer to the rear.
flat. Complete condensate drainage from the sterilization
chamber is only possible with a sufficient rearwards
incline.
Starting with the device in a level position, the fore
device feet are to be extended to the following
extent: Vacuklav 24 B+: min. five rotations,
Vacuklav 30 B+: three rotations.
The mains voltage is too low, poor Check the building-side socket / test the steam
building voltage supply (e.g. undersized sterilizer using a different socket or circuit.
installation, defective socket, multiple
devices on a single socket/fuse) so that
the steam generator cannot heat up.
F04 The chamber filter “Condensate return” Screw out the “Condensate return” filter (in the rear
is blocked. area of the chamber floor) and check whether it is
soiled/blocked. Clean the filter if necessary, see
Cleaning the filter in the chamber [} page 46].
The wastewater outflow is impeded. Check the installation of the wastewater hose. This
must be installed without kinking or sagging and at a
constant decline.
Check whether the building siphon is blocked.
PLEASE NOTE: If multiple devices are operated
simultaneously, we recommend the installation of an
additional siphon.
F06 The sterile filter is blocked. 1. Check whether the sterile filter suction aperture
(centre aperture) on the rear panel of the steam
sterilizer is blocked. If yes, replace it with a new
sterile filter, see Replacing or sterilizing the ster-
ile filter [} page 44].
2. If nothing can be recognized, remove the sterile
filter on the rear panel of the steam sterilizer and
perform a program run without a load. If the pro-
gram has been ended successfully, the sterile
filter is blocked. In this case, replace the sterile
filter.
F08 The internal device time monitoring is Check the building-side socket / test the steam
defective. sterilizer using a different socket or circuit or connect
to a mains filter. Upon repeated incidence, arrange
for an electrician to check the electricity supply for
electromagnetic disruption.
F09 The door has not been closed correctly Close the door correctly and start the program again.
upon program start. PLEASE NOTE: To shut the door correctly, press it
against the steam sterilizer lightly and slide the
locking slider downwards to its fullest extent.
An attempt was made to open the door Do not attempt to open the door during a program
during a program run. run.
F10 The overheat control of the steam Allow the steam sterilizer to cool for approx. 2 min
generator has triggered. and then restart the program.
PLEASE NOTE: This notification can be issued if a
program is started immediately after a malfunction or
a program abort.

52
12 Malfunctions

Incident Possible causes What you can do


F12 The door has not been closed correctly. To shut the door correctly, press it against the steam
sterilizer lightly and slide the locking slider
downwards to its fullest extent.
The locking pin for the door is stiff. Open the door, switch off the steam sterilizer and
press in the locking pin by hand. The pin must be
free-moving. If necessary, clean the locking pin.
F13 The water inflow tap has not been Open the water inflow tap completely and check the
opened or has been opened only central water inflow tap.
insufficiently.
The water pressure in the building is too Check the pressure of the building water supply. The
low or fluctuates. minimum flow pressure must amount to 1 bar at
3.5 l/min.
The water inflow hose is kinked. Check the installation of the wastewater hose. It
must be installed without kinking and may not be
crushed.
The vacuum pump motor protection Press the motor protection switch reset button back
switch has tripped. in.
The vacuum pump has suffered a A vacuum pump can be unblocked in the following
blockage e.g. following long shutdown fashion:
periods. 1. Press the motor protection switch reset button
back in.
2. Acknowledge the malfunction message and
open the door.
3. Switch off the steam sterilizer and disconnect
the power cable.
4. Remove the cover cap from the small round
opening in the front of the steam sterilizer.
5. Insert a approx. 8 mm wide slotted screwdriver
with a min. 13 cm shaft length into the opening
to its fullest extent (until the screw driver takes
purchase) and turn it in both directions to
resolve the blockage of the vacuum pump.
Repeat until the screw driver can be turned
easily.
6. Remove the screw driver and close the opening
with the cover cap.
7. Connect the power plug and activate the device.
The steam sterilizer is now ready for operation.
If a leakage water detector (water stop) is installed:
The leakage water detector is without Unplug the leakage water detector control device,
function. wait approx. 30 s and plug it back in again. A
switching noise on the water inflow tap (black box on
the water inflow tap) must be audible.
The inflow filter in the leakage water Clean the inflow filter in the leakage water detector
detector is blocked by soiling in the valve as follows:
building supply. 1. Close the water inflow tap and start a vacuum
test.
2. Wait until the device displays a malfunction
message and then switch it off.
3. Unscrew the leakage water detector valve on
the water inflow tap and check the inflow filter;
clean it if necessary.

53
12 Malfunctions

Incident Possible causes What you can do


F14 When using the external water storage container:
Air is located in the inflow line from the Check whether sufficient feed water is in the storage
storage container to the steam sterilizer. container; the end of the inflow hose is submerged in
water and that no air is being drawn in. Please note
that the container may stand max. 1.5 m deeper
than the steam sterilizer otherwise water cannot be
drawn in.
The suction filter of the external water Check whether the filter in the external water storage
storage container is soiled/blocked. container is soiled or blocked and clean if necessary.
When using a MELAG water treatment unit:
Residual air is in the feed system of the Acknowledge the malfunction message and start the
water treatment unit after initial program repeatedly until the malfunction message is
commissioning or after replacement of no longer displayed.
the mixed-bed resin cartridge.
The pressure tank of the MELAdem 47 Please note that after initial commissioning of a
is not sufficiently filled. MELAdem 47 it takes approx. one hour until the
pressure tank is sufficiently full with water.
The water inflow tap is not open or the Check whether the water inflow tap for the water
pressure tank of the MELAdem 47 is treatment unit is open. When using a MELAdem 47,
closed. also check whether the tap on the pressure tank is
open.
When using a central water treatment unit:
The central water supply has been Check whether all inflow valves from the central
interrupted or the flow pressure is system to the steam sterilizer are open. If necessary,
insufficient. arrange for an inspection of the flow pressure of the
central water treatment unit using a flow pressure
gauge (min. 0.5 bar at 5 l/min).
F18 Malfunction on the specified sensor Upon repeated incidence, contact an authorized
input customer services / stockist technician.
With "Malfunction 18 Sensor: 6 Input: 6" Check whether the water used as feed water
an excessively high conductivity of the actually corresponds to the required quality or e.g.
feed water supply can be measured. tap water has been used. The feed water must fulfil
the quality requirements of DIN EN 13060,
Appendix C. If tap water has been used, restart the
steam sterilizer 2-3 times so as to flush out the tap
water from the system.
F25 Very poor feed water quality (conductivity ≥ 65 µS/cm).
When using the external water storage container:
Water of insufficient quality e.g. tap Empty and clean the container and fill it with water of
water was used. the required quality (DIN EN 13060, Appendix C).
When using a MELAG water treatment unit:
MELAdem 40: MELAdem 40/53/53 C:
The mixed-bed resin cartridge is Replace the MELAdem 40 mixed-bed resin cartridge
exhausted. in accordance with the applicable user manual.
MELAdem 47/53: MELAdem 47:
The mixed-bed resin cartridge, the pre- Replace the mixed-bed resin cartridge and if
filter or the activated coal filter is necessary, the pre-filter and activated carbon filter of
exhausted. the MELAdem 47 in accordance with the applicable
operating manual. Empty the pressure tank (if
possible until it is half full) and wait until it has been
filled again. An empty pressure tank requires approx.
one hour to fill.
PLEASE NOTE: The notification may also continue
to be shown after the filter has been changed until
the water remaining in the pressure tank has been
consumed.

54
12 Malfunctions

Incident Possible causes What you can do


F28 Insufficient battery voltage in the device. Arrange for the battery to be replaced by customer
services / stockist customer services.
F29 Data loss in the internal device memory. 1. Acknowledge the malfunction message and then
Insufficient voltage of the device reset the date and time, see Setting the date
battery. and time [} page 19].
2. Start the program again.
F31 During the vacuum test, the permissible Allow the steam sterilizer to cool and rub the
maximum pressure was exceeded after sterilization chamber dry with a non-fuzzing cloth.
the evacuation pressure had been PLEASE NOTE: The sterilization chamber must be
achieved (serious leak). dry and cold to ensure a successful vacuum test.
The sterilization chamber is too hot or
too damp.
The door seal and/or the seal face on Check the door seal and the seal face on the
the sterilization chamber is soiled or the sterilization chamber for soiling and foreign bodies
door seal is defective. and clean them if necessary. Check the door seal for
defects and replace if necessary, see Replacing the
door seal [} page 43].
The door seal was not inserted Check whether the door seal has been inserted
correctly. correctly, see Replacing the door seal [} page 43].
Insert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.
F32 The steam sterilizer was switched off at Replace or sterilize the sterile filter as follows:
the power switch during a program run. 1. Remove the sterile filter from the rear panel of
the steam sterilizer and sterilize it in the
Gentle-Program without continuing loading.
2. Return the sterile filter to the rear panel.
Never switch off the steam sterilizer at the power
switch during a program run. Always abort a
program with the 'Start-Stop' key.
The power plug has been disconnected Check whether the power plug is connected, the
or has not been connected correctly in power cable has suffered damage or a loose contact
the socket. or loose plug connections is the cause. Plug the
power plug back into the mains socket.
Power outage in the building supply. Arrange for an inspection of the building-side
installation (e.g. automatic circuit breaker) and test
the steam sterilizer at another socket or on another
circuit.
F34 The sterilization temperature on Comply with the maximum permissible load
temperature sensor was undercut. quantities, see Loading the steam sterilizer
The steam sterilizer is overloaded. [} page 21]. If necessary, perform a vacuum test,
see Vacuum test [} page 39].
The door seal and/or the seal face on Check the door seal and the seal face on the
the sterilization chamber is soiled or the sterilization chamber for soiling and foreign bodies
door seal is defective. and clean them if necessary. Check the door seal for
defects and replace if necessary, see Replacing the
door seal [} page 43].
The door seal was not inserted Check whether the door seal has been inserted
correctly. correctly, see Replacing the door seal [} page 43].
Insert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.

55
12 Malfunctions

Incident Possible causes What you can do


F36 The required chamber pressure was Comply with the maximum permissible load
undercut during sterilization. quantities, see Loading the steam sterilizer
The steam sterilizer is overloaded. [} page 21]. If necessary, perform a vacuum test,
see Vacuum test [} page 39].
The door seal and/or the seal face on Check the door seal and the seal face on the
the sterilization chamber is soiled or the sterilization chamber for soiling and foreign bodies
door seal is defective. and clean them if necessary. Check the door seal for
defects and replace if necessary, see Replacing the
door seal [} page 43].
The door seal was not inserted Check whether the door seal has been inserted
correctly. correctly, see Replacing the door seal [} page 43].
Insert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.
F39 The internal memory (EEPROM) has 1. Acknowledge the malfunction message and then
suffered data inconsistency or data reset the date and time, see Setting the date
loss. and time [} page 19].
2. Start the program again.
F48 Parameter malfunction 1. Switch off the steam sterilizer and back on
again.
2. Restart the program.
F51 The sterilization temperature on Comply with the maximum permissible load
temperature sensor 2 was undercut. quantities, see Loading the steam sterilizer
The steam sterilizer is overloaded. [} page 21]. If necessary, perform a vacuum test,
see Vacuum test [} page 39].
The door seal and/or the seal face on Check the door seal and the seal face on the
the sterilization chamber is soiled or the sterilization chamber for soiling and foreign bodies
door seal is defective. and clean them if necessary. Check the door seal for
defects and replace if necessary, see Replacing the
door seal [} page 43].
The door seal was not inserted Check whether the door seal has been inserted
correctly. correctly, see Replacing the door seal [} page 43].
Insert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.

56
12 Malfunctions

Opening the door in an emergency following a power outage

WARNING
The steam sterilizer must be completely pressure free.
Failure to observe this provision can result in scalding / injury.
n No steam may be permitted to leave from between the sterile filter and the rear panel of the
steam sterilizer.
n The slide seal grip must be easy to actuate.
n It must be possible to push the door approx. 2 mm to the rear with light pressure.
n It is imperative that you allow the steam sterilizer to cool. Metal parts such as the door and
chamber can be hot.

Should it not be possible to open the door e.g. following a power outage, taking into account the safety
information specified above, proceed as follows:
1. Switch off the steam sterilizer at the mains and
remove the plug from the socket.

2. To effect emergency release of the door, position long


side of the lever between the door and the side wall of
the steam sterilizer. The curve points forwards; the
lever is at the level of the locking slider.

If the lever is in the guide, pull it forwards with your


right hand. Push the slide locking grip upwards with
your other hand.

Display with door unlocked

3. Open the door.

57
12 Malfunctions

Replacing the device fuses


If the device fuses have been tripped, proceed as follows to change them:
1. Switch off the steam sterilizer at the mains and
remove the plug from the socket.

2. Open the door manually, see Opening the door in


an emergency following a power outage
[} page 57].

3. Unscrew and remove the two screw caps in the fuse


holder on the lower front of the steam sterilizer with a
screw driver or coin.

Two replacement fuses are mounted on the inside of


the door (see marking).

4. Remove the defective fuses and insert the new fuses


securely in their holder.

5. Screw the cap of the fuse holder to the lower front


of the steam sterilizer.

6. Reconnect the steam sterilizer plug to the socket


and switch on the steam sterilizer at the power
switch.
Should this trigger repeatedly, please inform the authorized customer services / stockist technician.

58
13 Technical data

13 Technical data

Device type Vacuklav 24 B+ Vacuklav 30 B+


Device dimensions (H x W x D) 49.5 x 42.5 x 70.5 cm 49.5 x 42.5 x 66 cm
Empty weight 48 kg 45 kg
Operating weight 55 kg 50 kg
Sterilization chamber
Chamber diameter 25 cm
Chamber depth 45 cm 35 cm
Chamber volume 22.6 l 17 l
Electrical connection
Electricity supply 220-240 V, 50/60 Hz
Max. voltage range 207-253 V
Electrical power 2100 W
Building fuses separate power circuit with 16 A fuse, 30 mA RCD protection
Overvoltage category transient overvoltage up to the values of overvoltage category II
Degree of air pollution (acc. to category 2
DIN EN 61010-1)
Length of power cable 1.35 m
Surrounding conditions
Installation location interior of a building
Noise emission 63 dB(A)
Waste heat (with max. load) 0.6 kWh
Ambient temperature 5-40 °C (recommended max. 25 °C)
Relative humidity max. 80 % at 31 °C, decreases in a linear fashion up to max. 50 %
relative humidity at 40 °C
Degree of protection (following IP20
IEC 60529)
Max. altitude 2000 m
Cold water connection
Water quality drinking water
Recommended flow pressure 2.0-4.0 bar at 3 l/min
Min. flow pressure > 1.2 bar at 3 l/min
Max. water pressure (static) 10 bar
Max. water consumption4) approx. 57.5 l
Max. water temperature 20 °C (ideal 15 °C)
Feed water connection
Water quality distilled or demineralized feed water in accordance with DIN EN 13060,
Appendix C (with central demineralization system max. conductivity
5 µS/cm)
Recommended flow pressure 1.5 bar at 3 l/min
Min. flow pressure corresponding water treatment unit
Min. water pressure (static) corresponding water treatment unit
Max. water pressure (static) 10 bar
Max. water consumption4) approx. 720 ml approx. 770 ml
Wastewater connection
Max. water temperature short-term 90 °C
Max. flow rate short-term approx. 3.3 l/min

4)
In Prion-Program with porous full load.

59
14 Accessories and spare parts

14 Accessories and spare parts

You can obtain the specified articles and an overview of further accessories from your stockist.

Category Article Art. no.


Chamber Chamber
depth depth
45 cm 35 cm
Mounts Mount A Plus 82630 82620
for 5 trays or 3 MELAstore Box 100
Mount D 46840
for 2 high sterilization containers or 4 trays
Sterilization container with 15K (18 x 12 x 4.5 cm) 01151
a disposable paper filters 15M (35 x 12 x 4.5 cm) 01152
in accordance with
DIN EN 868-8 15G (35 x 12 x 8 cm) 01153
17K (20 x 14 x 5 cm) 01171
(depth x width x height)
17M, for 45 cm chamber depth (41 x 14 x 5 cm) 01172 --
17G, for 45 cm chamber depth (41 x 14 x 9 cm) 01173 --
23M, for 45 cm chamber depth (42 x 16 x 6 cm) 01231 --
23G, for 45 cm chamber depth (42 x 16 x 12 cm) 01232 --
28M (32 x 16 x 6 cm) 01284
28G (32 x 16 x 12 cm) 01285
Package holder Package holder (Ø 25 cm) 22420 22410
Trays Tray 00230 00280
Test body system MELAcontrol consisting of a Helix test body and 01080
250 indicator strips
MELAcontrol PRO consisting of a Helix test body 01075
and 40 indicator strips
Water treatment units MELAdem 40 ion exchanger 01049
MELAdem 47 reverse osmosis unit 01047
MELAjet spray pistol for MELAdem 40 27300
For documentation: MELAflash CF card printer inc. MELAflash CF card 01039
and card reader
MELAnet Box 40296
MELAprint 44 log printer 01144
Spare Parts Water stop 01056
Device fuses 20 A gRL 57589
Door seal 58512
Sterile filter 20160
Slide clips for mounts Plus, 10 pcs. 81235

60
Glossary

Glossary
Air leakage Delay in boiling
An air leakage is a location through which air can This refers to the phenomenon that it is possible
pass in and out without this being desired. Verifica- under certain circumstances to heat a fluid beyond
tion of the leakage serves to prove that the volume its boiling point without them boiling. This repre-
of air ingress in the chamber during the vacuum sents an unstable state; even low-level agitation
phase does not exceed a value which would pre- can produce a large bubble within the shortest
vent steam penetration of the sterilizer load and period, which expands explosively.
that the air leakage does not cause the possible
contamination of the sterilizer load during the dry- Demineralized water
ing phase. Water without the minerals usually found in normal
spring or tap water; is produced through ion ex-
AKI change of normal tap water. It is used here as feed
Abbr.: working group instrument preparation ( "Ar- water.
beitskreis Instrumentenaufbereitung")
DGSV
Authorized technician Abbr.: Deutsche Gesellschaft für Sterilgutver-
The term “authorized technician” refers to an em- sorgung (German Society German Society for
ployee of a customer service provider or stockist Sterile Supply). The DSGV training centres are
who has been trained and authorized by MELAG specified in DIN 58946, part 6 as "Requirements of
to perform maintenance and installation work on personnel".
MELAG devices. Only they may carry out this
work. DIN 58946-7
Standard – sterilization - steam steam sterilizers -
Batch part 7: Building requirements and requirements
The batch is the composition of items which has placed on the operating agents and the operation
been subject to the same decontamination of steam sterilizers in the health-care branch
procedure.
DIN 58953
BGV A1 Standard – sterilization, sterile equipment supply
BGV is the abbreviation for Berufsgenossenschaft-
liche Vorschriften (regulations from a professional DIN EN 13060
association). A1 stands for principles of prevention Standard – small steam sterilizers

Bowie & Dick test DIN EN 867-5


Steam penetration test with a standard test Standard – non-biological systems for use in
package; described in DIN EN 285; the test is sterilizers – part 5: The determination of indicator
recognized in the large-scale sterilization industry. systems and test bodies for the performance
inspection of type B and type S small sterilizers.
CF card
The CF card is a memory medium for digital data; DIN EN ISO 11140-1
Compact Flash is an official standard, i.e. these Standard – the sterilization of products for use in
memory cards can be used in every device fitted medical treatment – chemical indicators – part 1:
with the corresponding slot. The CF card can be General requirements
read by every device that supports the standard
and where necessary, written on. DIN EN ISO 11607-1
Standard - packaging for medical devices to be
Condensate sterilized in the final packaging - Part 1: Require-
Fluid (e.g. water) produced by the cooling of and ments placed on materials, sterile barrier systems
resultant separation from the vaporous state. and packaging systems

Conductivity Distilled water


Conductivity refers to the ability of a conductive From the Latin aqua destillata; also referred to as
chemical material or mixture to conduct or transfer aqua dest; water which to a great extent is free
other materials or particles. from salts, organic material and micro-organisms,
is produced from normal tap water or pre-cleaned
Corrosion water through the process of distillation
The chemical alteration or destruction of metal (evaporation and subsequent condensation). It is
materials by water and chemicals used here as feed water.

61
Glossary

Dynamic pressure test of the sterilization chamber Process evaluation system


Serves to prove that the rate of pressure variations Also known as the self-monitoring system – this
during a sterilization cycle does not exceed a observes itself and compares the various sensors
particular value which could result in the damage during a current program.
of the packaging material. [see also
DIN EN 13060] Product with narrow lumen
An article open on one side to which the following
Empty chamber test applies: 1 ≤ L/D ≤ 750 and L ≤ 1500 mm or an
Test run without a load, performed to assess the article with an opening on both sides which is: 2 ≤
performance of a sterilizer without the influence of L/D ≤ 1500 and L ≤ 3000 mm and which does not
a load; facilitating verification of the temperatures correspond to a hollow body article B; L…length of
maintained in comparison to the temperatures set. hollow body article; D…Diameter of hollow body
[see also DIN EN 13060] article [see also DIN EN 13060]

Feed water RKI


Feed water is required to produce steam for Abbr.: "Robert-Koch-Institute". It is one of the most
sterilization. Guide values for water quality in important bodies for the safeguarding of public
accordance with DIN EN 285 / DIN EN 13060 – health in Germany.
Appendix C
Simple hollow bodies
Heat-up phase An article open on one side to which the following
The time required after the steam sterilizer has applies: 1 ≤ L/D ≤ 5 and D ≥ 5 mm or an article
been switched on / after the start of a sterilization with an opening on both sides which is: 2 ≤ L/D ≤
program, to heat the double-jacket steam genera- 10 and D ≥ 5; L…hollow body article length; D…
tor before the sterilization procedure starts. The hollow body article diameter [see also
duration is dependent on temperature at which DIN EN 13060]
sterilization takes place.
Single wrapping
Hollow body A Wrapped once e.g. instruments sealed in foil – in
See product with narrow lumen opposition to: Multiple wrapping

Hollow body B Soft sterilization packaging


See simple hollow body e.g. a paper bag or transparent sterilization
packaging.
Mixed loads
wrapped and unwrapped sterilization material Solid
within a single load Without hollows or gaps, solid, compact, closed

Multiple wrapping Solid load


e.g. wrapped instruments sealed in a double layer Serves to prove that the necessary sterilization
of film or wrapped in film and placed in an conditions have been reached within the entire
additional container or a container wrapped in load with the values set in the control. The load
textiles. must represent the largest weight of massive
instruments designed for sterilization in a sterilizer
Porous in accordance with DIN EN 13060. [see also
Permeable for fluids and air e.g. textiles DIN EN 13060]

Porous full load Sterile barrier system


Serves to prove that the values set on the control A closed minimum packaging which prevents the
satisfy the necessary sterilization conditions in entrance of micro-organisms e.g. through sealing
porous loads with a maximum mass for which the bags, sealed and re-usable containers and folded
sterilizer is designed in accordance with sterilization towels etc.
DIN EN 13060 [see also DIN EN 13060].
Sterilization chamber
Porous partial load The interior of a sterilizer accommodates the
Serves to prove that the values set on the control sterilization material
allow steam to enter the pre-determined test
package quickly and equally [see also Sterilization material
DIN EN 13060] Unsterile, sterilizable material which is still to be
sterilized.

62
Glossary

Sterilized equipment
Also referred to as a batch: a load which has
already been sterilized, i.e. is sterile

Vacuum
In common parlance, an area devoid of all material
In the technical sense: volumes with a reduced gas
pressure (at least air pressure)

63
BA_24B+_30B+_10054_10050_EN.pdf | Rev. 15 - 20/2651 | Modification date: 2020-11-18
MELAG Medizintechnik GmbH & Co. KG
Geneststraße 6-10
10829 Berlin
Germany
Email: [email protected]
Web: www.melag.com
Original instructions

Responsible for content: MELAG Medizintechnik GmbH & Co. KG


We reserve the right to technical alterations

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